Monoqool
DK-MF-000025532 · Denmark · Fredensborg
Monoqool is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 5 |
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Catalogue references include LG2000m, LW1163s, MY5131s, SK2012m, TI9095m.
European nomenclature codes declared: Q02100203.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MONOQOOL (DK) · FDA 3009316537 |
| Devices in EUDAMED | 5 |
| Country of registration | Denmark |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
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⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Monoqool is registered in the United States but was not found in the Canadian register.